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Page 2 of 2 NOTICE OF INTENT TO SOLE SOURCE: The Department of Veterans Affairs Network Contracting Office 4, 1010 Delafield Road, Pittsburgh, PA 15215, intends to award a sole source Firm-Fixed-Price... Page 2 of 2 NOTICE OF INTENT TO SOLE SOURCE: The Department of Veterans Affairs Network Contracting Office 4, 1010 Delafield Road, Pittsburgh, PA 15215, intends to award a sole source Firm-Fixed-Price Contract to Lantheus Medical Imaging, Inc. for the delivery of the following imaging agent equipment that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer on site at the Corporal Michael J. Crescenz VA Medical Center (CMCVAMC). This contract action is for supplies for which the Government intends to solicit from a single source under the procedures in FAR 13.106-1(b) used in accordance with 48 CFR 13.106-1. Interested parties may identify their interest and capability to respond to the requirement or submit quotes. The North American Industry Classification System (NAICS) for this requirement is 339112 with a small business size standard of 1,000 employees. THIS NOTICE OF INTENT IS NOT A REQUEST FOR COMPETITIVE QUOTATIONS. Responsible sources may identify their interest by submitting capability information by 3:00 P.M., EST, on Monday, November 1, 2021, in order to establish the ability of the source to meet this requirement. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. The Government will not be responsible for any costs associated with the preparation of responses to this notification. All inquiries and submittals must be sent via email to LaShawn Knight, Contract Specialist, at lashawn.knight@va.gov. Telephone inquiries will not be accepted. Item Number Unit QTY Description 0001 EA 144 PYLARIFY (piflufolastat F 18) Injection CPL Michael J. Crescenz Veterans Administration Medical Center Statement of Need Client Philadelphia Veterans Administrative Medical Center Job Name PYLARIFY (piflufolastat F 18) Requested by Nuclear Medicine Service From Gerald Watts Radiology Service Summary The Corporal Michael J. Crescenz VA Medical Center (CMCVAMC) in Philadelphia requires a licensed vendor by the Nuclear Regulatory Commission to provide radiopharmaceuticals to the Nuclear Medicine Department. This radiopharmaceutical PYLARIFY (piflufolastat F 18) is required for imaging procedures that aid in the diagnosis of prostate cancer. These items are to be delivered directly to the Diagnostic Imaging section of Nuclear Medicine (secured receiving areas), room 3A101B, Philadelphia VA Medical Center, Department of Veterans Affairs, 3900 Woodland Avenue, Philadelphia, Pennsylvania 19104. Project Scope This SOW covers the following activities and deliverables. The vendor agrees to perform these services with the standard of care, skill, and diligence normally provided by a professional organization in the performance of similar services. It is understood that the contractor must perform the services based, in part, on information furnished by this Medical Center; however, the vendor is given notice that the Medical Center will be relying on the accuracy, competence and completeness of the contractor s services in utilizing the results of such services. The Nuclear Medicine authorized staff of CMCVAMC, when needed for next day delivery during work hours will place all orders daily. There may be orders placed during other than normal working hours, to be delivered in an emergency. The vendor must be able to fulfill this requirement. All items are to be delivered to the Nuclear Medicine department as specified above. The CMCVAMC will require credit statements (itemized returned doses) and monthly invoices. Electronic daily dose tracking systems should be available for the Medical Center s use in certifying and tracking per patient doses delivered. Deliverables: PYLARIFY (piflufolastat F 18) The Contractor shall have available an adequate supply of contract products to meet the requirements of the CMCVAMC Healthcare System. The Contractor shall label all unit doses of delivered radiopharmaceuticals with the amounts, preparation time, expiration time, date, etc., and provide a bar labeled insert to allow scanning data into the nuclear medicine information management system (NMIS). If the Contractor s system varies from our current (Pinestar) NMIS information system, the Contractor shall provide their system as well as data migration, technical support and training of staff on its use at no additional Price to the Government. All packaging of radioactive material MUST BE clearly labeled RADIOACTIVE with the proper class and exposure levels on the outside of the shipping container. The Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies. The Contractor shall meet all Nuclear Regulatory Commission, Department of Transportation, NHPP, FDA, OSHA and all other agency rules and regulations (Federal and State). Radiopharmaceutical Returns for Credit: The Contractor shall be responsible to accept returns for full credit towards future orders only under the following conditions: Product(s) ordered or shipped in error Product(s) damaged in shipment Concealed shipping damages Recalled product(s) Outdated product(s) in unopened, original container (specifically authorized for return by manufacturer). The Contractor shall invoice at least once per month showing period covered, billing date, name of preparation, quantity, and amount. Schedule Authorized VA Nuclear Medicine personnel shall place orders during the normal workday, and first delivery shall be received no later than 8:00 am the following workday to the CMCVAMC Nuclear Medicine Department. Depending on Medical Center patient care requirements, the contractor shall provide routine delivery and pick-up as many times as required by the CMCVAMC. The delivery order shall include contract item(s) and quantity, time of delivery, and applicable VA order number. Only authorized CMCVAMC personnel via telephone, fax, or e-mail shall be allowed to place orders. Contractor agrees to accept unused radiopharmaceutical and provide reimbursement per unit dose applicable towards future orders. After award, the CMCVAMC Nuclear Medicine department will furnish the name(s) of all personnel who are authorized to place orders against the Contract. The Contractor will be furnished with a copy of the user s license as per Nuclear Regulatory Commission guidelines. Same-Day Delivery Same-Day Delivery requires delivery and receipt at the CMCVAMC Nuclear Medicine department no later than 4 hours after order is placed during normal business hours. Nuclear Medicine normal business hours are considered Monday through Friday: 6:30 am 4:30 pm except Federal Holidays. The following are Federal Holidays: New Year s Day Martin Luther King Jr. Day President s Day Memorial Day Independence Day Labor Day Columbus Day Veteran s Day Thanksgiving Day Christmas Day Pricing Items will be in unit dose, daily, and on an as needed basis in accordance with patient requirements. Key Assumptions All annual quantities are estimates, contractor will only be paid for items and quantities that are ordered and delivered. End of Document